CStone announces first patient dosing with anti-PD-1 antibody CS1003 in Phase I study in Australia——Second pipeline candidate to enter Phase I studies in Australia within one month

Time: 2018.05.14 Browsing times: Authors: admin

SUZHOU, China, May 14, 2018

CStone Pharmaceuticals (CStone) today
announced dosing of the first patient in a Phase I clinical trial in Australia
for CS1003, an investigational anti-programmed death-1 (PD-1) monoclonal
antibody (mAb). The open-label, first-in-human (FIH) study is initiated at
Scientia Clinical Research Ltd in Australia and will investigate the safety,
tolerability, and preliminary efficacy of CS1003 in patients with advanced
solid tumors.

“We are excited to announce initiation of
clinical development for PD-1 inhibitor CS1003, our second pipeline candidate
to enter Phase I studies in Australia after the CTLA-4 mAb CS1002 within one
month,” said Dr. Frank Jiang, Chief Executive Officer at CStone. “CS1003 is
cross-reactive with human and mouse PD-1 which enables quick pre-clinical proof
of concept experiments in combination with novel targets, leading to global
first-in-combination potential. Because of this unique feature, CS1003 is
critical to CStone’s combination strategy in cancer immunotherapy.”

The launch of clinical studies for CS1003 is
a key milestone for CStone, which now has three important checkpoint inhibitors
for cancer therapy under clinical development. Alongside CS1001 (PD-L1) and
CS1002 (CTLA-4), CS1003 will provide the backbone for CStone’s pipeline development
of oncology combination therapies.

As noted by Dr. Jason Yang, Chief Medical
Officer of CStone, “In preclinical studies, CS1003 demonstrated high affinity
and selectivity for PD-1, as well as synergistic anti-tumor effects with multiple
small-molecule drugs in animal models. The launch of this clinical program will
allow us to gather important safety and efficacy data on CS1003. This will lay
the foundation for future development of this molecule, in particular as the
basis of combination therapies.”

“We are excited to be enrolling our first
patient treated with CS1003 and are hopeful that this novel immunotherapy drug
will add to the available therapeutic options for advanced-stage tumors, either
by itself or in combination with other drugs,” said Dr. Charlotte Lemech, MBBS,
BSc, FRACP, MD, lead investigator for this trial at Scientia Clinical Research
Ltd.

The Phase Ia/Ib study includes a
dose-escalation stage followed by a dose-expansion stage. Additional
information on the trial can be found here.

About
CS1003 and the PD-1/PD-L1 pathway

CS1003 is a humanized anti-PD-1 IgG4
monoclonal antibody developed by CStone using an internationally leading hybridoma
platform. CS1003 has shown good tolerability and efficacy profile in
preclinical in vivo studies.

PD-1, or programmed death-1, is an
inhibitory checkpoint receptor expressed on T cells. Under normal circumstances,
it binds with its ligands, programmed death ligand-1 or ligand 2 (PD-L1/PD-L2),
inhibiting T cell and cytokine activation, serving to dampen the immune
response in order to prevent damage to healthy tissues. However, studies have
shown that PD-L1 can be abundantly expressed on the surface of many solid
tumors as well as hematological malignancies. Cancer cells can therefore make
use of the PD-1/PD-L1 pathway to successfully avoid immune system recognition
and attack. Targeting of the PD-1/PD-L1 checkpoint by anti-tumor drugs can
block the “tumor immune evasion mechanism" and restore anti-cancer immune
ability in patients.

CStone Pharmaceuticals is a biopharmaceutical
company devoted to the development of innovative drugs. With a broad oncology
pipeline, the company is focused on the development of immuno-oncology based combination
therapies. All members of the management team are seasoned executives from top
multinational pharmaceutical companies. CStone has successfully built up an
industry leading team with clinical development and translational medicine as
its core competence. CStone has gained the backing of prestigious VC/PE funds in
two financing rounds to date, raising $150 million in a Series A round in July
2016, followed by $260 million in a Series B round in May 2018. With an experienced team, a rich pipeline, a robust R&D
model, and substantial funding, CStone is well positioned as the partner of
choice for multinational pharmaceutical / biotech companies to develop drugs in
China and the Asia-Pacific region.